Encore Medical, LP: Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis

Hazard

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

Details from the source

Reason for recall: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. Distribution: U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA Quantity: 20 Lot/code info: Lot Code: Item: 341-12-711 GTIN: 00888912166980 Lot: 115T1077

UPC codes

00888912166980

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.